Analysis of Competitive Posterior Cruciate Retaining (PCR) and Posterior Stabilized (PS) Total Knee Arthroplasty (TKA)

Study Purpose

The purpose of the study is to acquire kinematic in vivo fluoroscopy data from subjects who were implanted with Stryker Posterior Cruciate Retaining (PCR) , Stryker Posterior Stabilized (PS), Zimmer PCR, and Zimmer PS Total Knee Arthroplasty (TKAs). Our lab has previously collected data for the Smith & Nephew PCR, bi-cruciate retaining (BCR), and bi-cruciate stabilized (BCS) TKA.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years - 85 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Subjects will have one of the following implant types: 1) Stryker Triathlon PCR TKA (28 subjects), 2) Stryker Triathlon PS TKA (28 subjects), 3) Zimmer Persona PCR TKA (28 subjects) and 4) Zimmer Persona PS TKA (28 subjects). 2. Patients must be at least three months post-operative. 3. Participants must not experience any pain or other post-operative complications. 4. Participants must have a stable TKA and be capable of performing a deep knee bend activity. 5. Participants must weigh less than 300 lbs., not underweight (BMI < 18.5) or too obese (BMI>35). 6. Must be in the age range of 18 years to 85 years (both inclusive). 7. Participants must be able to perform the required activities without concern. 8. Subjects must be willing to sign the Informed Consent (IC) form to participate in the study. 9. Patients who do not have previous surgery on the implanted knee that might restrict their movement.

Exclusion Criteria:

1. Pregnant, potentially pregnant, lactating females or of childbearing age. To satisfy radiation protocol, each female subject will be asked if she is pregnant, or possibly could be pregnant. A pregnant person will not be allowed to participate in the study. (All potential female study patients will be asked if they are premenopausal or if they have undergone a hysterectomy. If the possibility of pregnancy exists, a pregnancy kit will be given to the patient at the informed consent meeting, just prior to the fluoro. Results of the test will be recorded in a test log. Any female patient showing a positive test will be excluded from testing.) 2. Subjects without the required type of knee implant. 3. Cannot have pain in other parts of the body that would prohibit the subject from performing the activities). 4. Cannot have ligamentous pain and/or laxity. 5. Unwilling to sign IC/HIPAA form(s). 6. Does not speak English. 7. Patients who have enrolled in a fluoroscopic kinematic study within the past year. 8. Patients currently involved in any personal injury litigation, medical/legal or worker's compensation claims. 9. Patients with known drug or alcohol abuse histories or psychological disorders that could affect ability to complete all aspects of the study. 10. Patients with neurological or musculoskeletal disorders that might adversely affect weight-bearing motion ability.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04321356
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

The University of Tennessee, Knoxville
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Richard Komistek, PhD
Principal Investigator Affiliation The University of Tennessee
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherIndustry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Knee Osteoarthritis, Total Knee Arthroplasty, Knee
Additional Details

The objective for this study is to analyze the in vivo kinematics for subjects implanted with either a Stryker PCR, Stryker PS, Zimmer PCR, and Zimmer PS TKA and to compare those patterns to subjects having a normal knee from our previous study and to those patterns from subjects having a Smith & Nephew PCR, BCR, and BCS TKA.

Arms & Interventions

Arms

: Stryker Triathlon PCR TKA

Subjects implanted with a Stryker Triathlon PCR TKA

: Stryker Triathlon PS TKA

Subjects implanted with a Stryker Triathlon PS TKA

: Zimmer Persona PCR TKA

Subjects implanted with a Zimmer Persona PCR TKA

: Zimmer Persona PS TKA

Subjects implanted with a Zimmer Persona PS TKA

Interventions

Device: - Triathlon PCR TKA

Total Knee Arthroplasty System

Device: - Triathlon PS TKA

Total Knee Arthroplasty System

Device: - Persona PCR TKA

Total Knee Arthroplasty System

Device: - Persona PS TKA

Total Knee Arthroplasty System

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Tennessee Orthopaedic Clinic, Knoxville, Tennessee

Status

Recruiting

Address

Tennessee Orthopaedic Clinic

Knoxville, Tennessee, 37923

Site Contact

Harold Cates, MD

[email protected]

865-690-4861

The University of Tennessee, Knoxville, Tennessee

Status

Not yet recruiting

Address

The University of Tennessee

Knoxville, Tennessee, 37996

Site Contact

Richard Komistek, PhD

[email protected]

865-974-4159